Global UDI
$56,592–$89,548 year
Hybrid · Raynham, Massachusetts, United States or Ringaskiddy, Munster, Ireland
Job Summary
Global UDI role responsible for ensuring DePuy Synthes’s global compliance with UDI regulatory requirements through robust quality oversight of enabling technologies, systems, and processes. Partners cross-functionally with Regulatory Affairs, IT, Supply Chain, and Manufacturing to ensure UDI data accuracy, system validation, and sustained compliance across global markets. Provides oversight for global UDI technology platforms, data flows, and supporting systems; develops, implements, and maintains UDI-related quality processes; validates systems; reviews UDI-related documentation; monitors data accuracy and timeliness; supports audits/inspections; identifies quality risks and drives corrective and preventive actions; provides quality guidance and training; travel up to ~15% (domestic and occasional international).
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Information Systems, Life Sciences, or a related discipline
- Typically 4–8 years of experience in Quality Assurance, Quality Systems, or Regulatory-adjacent roles within medical devices, pharmaceuticals, or regulated industries
- Experience supporting validated systems and technology platforms in a regulated environment
- Working knowledge of global UDI regulations (e.g., FDA, EU MDR) and quality system requirements
- Experience with change control, risk management, and documentation review within a quality framework
- Demonstrated ability to analyze quality data, identify trends, and drive continuous improvement
- Preferred: Experience with UDI databases, labeling systems, or enterprise data management platforms
- Familiarity with computer system validation (CSV) and digital quality controls
- Experience supporting regulatory inspections or audits related to data integrity or digital systems
- Knowledge of Lean, Six Sigma, or continuous improvement methodologies
- Experience working in a global or matrixed organization
- Strong collaboration skills with the ability to work effectively across global, cross-functional teams
- Language: English proficiency required
- Certifications: ASQ certifications (e.g., CQA, CQE) or similar quality certifications preferred
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